IS 16011 : 2012

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Indian Standard ALUMINIUM AND ALUMINIUM ALLOY FOIL FOR PHARMACEUTICAL PACKAGING -- SPECIFICATION

ICS 11.120.01; 55.040; 77.150.10

© BIS 2012

BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI 110002

November 2012

Price Group 3

Light Metals and Their Alloys Sectional Committee, MTD 7

FOREWORD This Indian Standard was adopted by the Bureau of Indian Standards, after the draft finalized by the Light Metals and Their Alloys Sectional Committee had been approved by the Metallurgical Engineering Division Council. The aluminium and aluminium alloy foil play an important role in pharmaceutical packaging due to their unique barrier properties. Packaging with these foils exclude moisture, oxygen and other gases, micro-organisms and light, thus maintaining sensitive products in peak condition for long periods. Their various properties provide a convenient, safe and versatile packaging format for tablets, creams, liquids and powders covering an enormous variety of pharmaceutical products. On the request of stakeholders, the Committee decided to formulate an Indian Standard to cover the various technical requirements. The composition of the Committee responsible for the formulation of this standard is given in Annex A. For the purpose of deciding whether a particular requirement of this standard is complied with the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2 : 1960 `Rules for rounding off numerical values (revised)'. The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard.

IS 16011 : 2012

Indian Standard ALUMINIUM AND ALUMINIUM ALLOY FOIL FOR PHARMACEUTICAL PACKAGING -- SPECIFICATION
1 SCOPE This standard covers the requirements of aluminium and aluminium alloy-bare / coated / laminated foil for pharmaceutical packaging applications. It is applicable for 0.020 mm (20 µm) to 0.040 mm (40 µ m) foil thicknesses. 2 REFERENCES The following standards contain provisions, which through reference in this text constitute provisions of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below: IS No. 737 : 2008 Title Wrought aluminium and aluminium alloy sheet and strip for general engineering purposes ( fourth revision) Glossary of terms relating to aluminium and aluminium alloys: Part 1 Unwrought and wrought metals (second revision) General conditions for delivery and inspection of aluminium and aluminium alloy products 3.4 Pharma Laminate -- Laminated foil (with foil thickness of 30-40 µ) with one side laminated and other side coated with primer or printed used for strip pack application for pharmaceutical packaging. 4 MANUFACTURE Unless otherwise specified, the production and manufacturing processes shall be left to the discretion of the manufacturer. 5 PINHOLE COUNT Pinhole count shall be mutually agreed upon between the purchaser and the supplier. However, a guideline for pinhole count is given in Table 1. Table 1 Pinhole Count
Sl No. Nominal Thickness Dimensions in mm (2) 0.020 0.025 0.030 > 0.040 Dimensions in µm (3) 20 25 30 > 40 Pinhole Count No./m2 Max (4) 25 20 10 5

(1) i) ii) iii) iv)

5047 (Part 1) : 1986

10259 : 1982

6 FREEDOM FROM DEFECTS The foil shall be well finished, uniform in quality, free from splits, slivers, wrinkles, ragged edges and oil staining. If supplied in coated/laminated condition the coating/lamination shall be uniform. There shall be no delaminated areas. 7 MATERIAL 7.1 The material used for aluminium and aluminium alloy foil shall conform to the chemical composition of the Grades 19000, 19500, 19600, 31000 or 40800 of IS 737. 7.2 Unless otherwise specified by the purchaser, bare blister pack foil shall be supplied in `as rolled' condition without a final annealing treatment. 7.3 Unless otherwise specified by the purchaser, bare pharma strip pack foil shall be supplied in fully annealed condition. 7.4 Unless otherwise specified by the purchaser, coated 1

3 TERMINOLOGY For the purpose of this standard, the definitions given in IS 5047 (Part 1) and the following shall apply. 3.1 Bare Blister Pack Foil -- Bare foil (of thickness 20-25 µ without any lamination or coating) used for blister pack application for pharmaceutical packaging usually after coating. 3.2 Coated Blister Pack Foil -- Bare foil (of thickness 0.20-25 µ) with one side coated with heat seal lacquer and the other side with primer or printed, used for blister pack application in pharmaceutical packaging. 3.3 Bare Pharma Strip Pack Foil -- Bare foil (of thickness 30-40 µ without any lamination or coating) used for strip pack application for pharmaceutical packaging.

IS 16011 : 2012 blister pack foil shall be supplied with one side of as rolled foil (without a final anneal) coated with heat seal lacquer and the other side coated with shellac or printed. 7.5 Unless otherwise specified by the purchaser, pharma laminate shall be supplied with one side of fully annealed foil laminated with 35 gsm LDPE and other side coated with shellac or printed. 8 SUPPLY OF MATERIAL General requirements relating to the supply of aluminium and aluminium alloy foil shall conform to IS 10259. 9 LUBRICANTS As the foils are to be used in pharmaceutical applications they shall be produced with rolling oils/ lubricants which do not contain substances which are injurious to health or have any deleterious effect on the flavour, odour or appearance of pharmaceutical products. 10 PREFERRED THICKNESSES Unless otherwise stated, the preferred thickness shall be as given in Table 2. Table 2 Preferred Thicknesses
Sl No. Nominal Thickness Dimensions in mm (2) 0.020 0.025 0.030 0.040 Dimensions in µm (3) 20 25 30 40 Nominal Covering Area m2/kg (4) 18.5 14.8 12.3 9.26 Sl No. (1) i)

12 COATING/LAMINATION 12.1 Pharma Laminate It shall have one side laminated with 35 gsm LDPE. Non-laminated side shall have primer coating with Shellac or shall be printed as desired by the purchaser. 12.2 Coated Blister Pack Foil It shall have one side of the aluminium foil coated with heat sealant lacquer with a coating weight in the range of either 4-6 gsm or 6-8 gsm depending on mutual agreement between the purchaser and the supplier. Primer coating with Shellac or printing shall be done on the non-heat seal side. 12.3 Winding Coated blister pack foil shall be so wound so that the primer-coated side is on the outside surface. 13 DIMENSIONS AND TOLERANCES 13.1 Unless otherwise agreed, the thickness tolerance for bare foil shall be ±8 percent and the thickness tolerance for laminated products (including the foil and lamination together) shall be ± 8 percent. 13.2 Unless otherwise stated, the width tolerances shall be as given in Table 3. Table 3 Width Tolerances
Product Tolerance on Width for Width <1 000 mm (3) 0.5 >1 000 mm (4) 1.0

(1) i) ii) iii) iv)

(2) All

14 MECHANICAL PROPERTIES 14.1 Bursting Strength Bursting strength for bare strip pack foil and pharma laminate shall be as per Table 4.
NOTE -- Bursting strength is only applicable for bare strip pack foil or pharma laminate. It is not applicable for bare blister pack foil or coated blister pack foil.

11 AVERAGE THICKNESS OF BARE FOIL 11.1 The determination of average thickness shall be carried out using a method giving accurate and repeatable results. 11.2 In case of dispute, the average thickness may be determined by the gravimetric method, based on weighing a sample of 100 mm × 100 mm area, shall be dried and weighed on a balance, accurate to at least 0.5 mg Thickness of the foil, in mm =
W 27.1

14.1.1 Description of Test Method The material is submitted to a uniform pressure distributed over a known surface area and the bursting pressure is measured to give an indication of the suitability of the material. 14.2 Peel Strength (for Pharma Laminate) Peel strength is only applicable for pharma laminate and shall be as per Table 5.

where W is the mass of the foil sample ( 100 mm × 100 mm), in g.

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IS 16011 : 2012 Table 4 Bursting Strength (Clause 14.1)
Sl No. Product Nominal Thickness Dimensions in mm (2) a) b) c) d) ii) For laminated: a) b) 0.030 0.040 30 40 2.2 2.8 (3) 0.020 0.025 0.030 0.040 Dimensions in µm (4) 20 25 30 40 Bursting Strength (kg/cm2) Min (5) 1.4 1.7 2.0 2.6

16 SAMPLING 16.1 Unless otherwise agreed to between the purchaser and the manufacturer the following procedure and the criteria for conformity shall apply. 16.2 In a consignment the foils of same width and thickness and of the same surface condition and manufactured by a single firm under essentially similar conditions of production shall be grouped together to constitute a lot. 16.2.1 Tests for determining the conformity of the lot to the requirement of this standard shall be carried out on each lot separately. The number of rolls of foils to be selected for this purpose at random over the whole lot shall be in accordance with col 2 and col 3 of Table 7. Table 7 Scale of Sampling and Permissible Number of Defectives (Clauses 16.2.1 and 16.2.2)
Sl No. (1) i) ii) iii) iv) v) vi) No. of Rolls in the Lot (2) Up to 15 16 to 25 26 to 50 51 to 100 101 to 300 > 300 No. of Rolls to be Selected (3) 5 8 13 20 32 50 Permissible No. of Defectives (4) 0 1 1 2 3 3

(1)

i) For Bare foil:

Table 5 Peel Strength (Clause 14.2)
Sl No. Product Nominal Thickness Dimensions in mm (2) a) b) (3) 0.030 0.040 Peel Strength Dimensions (g/25 mm) in µm Min (4) (5) 30 40 250 250

(1)

i) For Bare foil:

14.3 Sealing Strength (for Coated Blister Pack Foil and Pharma Laminate) Sealing strength is only applicable for coated blister pack foil and pharma laminate and shall be as per Table 6. Table 6 Sealing Strength
Sl No. Product Nominal Thickness Dimensions in mm (3) a) b) c) d) 0.020 0.025 0.030 0.040 Sealing Strength Dimensions (g/25 mm) in µm Min (4) (5) 20 25 30 40 500 500 500 500

16.2.2 All the rolls shall be individually examined for manufacturing defects, surface defects and dimensional tolerances. A sample failing to meet any one of these requirements shall be called defective. The lot shall be considered as conforming to the corresponding requirements of this standard if number of defectives satisfy the freedom from defects and dimensions in less than or equal to the permissible number given in col 4 of Table 7. 17 ORDERING INFORMATION The order shall include the following information: Quantity, in kg; Nominal thickness; Foil size; Dimensions of rolls (outside diameter, in mm); e) Type and inside diameter of the core in mm; length of core (if different from the width of the rolls); f) Surface condition; and g) Packing mode. a) b) c) d)

(1)

(2)

i) For Bare foil:

15 SURFACE CONDITION 15.1 For coated blister pack foil one of the foil surfaces is bright and the other surface is matte. 15.2 For pharma laminate either one of the foil surfaces is bright and the other surface matte or both the surfaces may be bright depending on requirements of the purchaser.

3

IS 16011 : 2012 18 MARKING 18.1 Each package of bare or converted aluminium foil may be suitably marked for identification with the name of manufacturer, grade, condition of the material, batch No. and date of manufacture. 18.1.1 The foil package may also be marked with the Standard Mark. 18.2 BIS Certification Marking 18.2.1 The use of the Standard Mark is governed by the provision of the Bureau of Indian Standards Act, 1986 and the Rules and Regulations made thereunder. The details of conditions under which the licence for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards.

ANNEX A (Foreword)
COMMITTEE COMPOSITION Light Metals and Their Alloys Sectional Committee, MTD 7
Organization Hindalco Industries Ltd (R&D Centre) Taloja, Navi Mumbai Aluminium Association of India, Bangalore Aeronautical Development Establishment, Bangalore BEML Ltd, Bangalore Bharat Aluminium Co Ltd, Korba Representative(s) SHRI SUBHANKAR G UPTA (Chairman) PROF K. S. S. MURTHY SHRI N. C. SUD (Alternate) SHRI G. S. RAVINDRA SHRI T. MOHAN REDDY (Alternate) SHRI H. S. PRAKASH SHRI R. NANDA NANDAN (Alternate) SHRI S. PRASAD SHRI NARAIN BALAKRISHANA (Alternate I) SHRI K. KARMAKAR (Alternate II) DR P. RAGOTHAN RAO SHRI KISHORE SHETTY (Alternate) SHRI V. K. SACHDEVA SHRI V. O. JANARDHANAN (Alternate) SHRI B. DASGUPTA SHRI M. A. KHAN (Alternate) DR AMOL A. GOKHALE DR VIJAY SINGH (Alternate) DR S. SUNDARRAJAN DR G. RAJA SINGH (Alternate) SHRI ALOK NAYAR SHRI PRAMOD N. KOPARDE SHRI ATUL GUPTA (Alternate) DR R. R. BHATT SHRI T. S. NANJUNDA SWAMY SHRI RAJENDRA HULYAL (Alternate) SHRI K. S. SATYANARAYANA SHRI A. K. ANAND (Alternate I) DR H. SUNDARA MURTHY (Alternate II) SHRI J. MUKHOPADHYAY DR K. V. RAMANA RAO (Alternate I) SHRI R. N. CHAUHAN (Alternate II) SHRI K. R. RAGHUNATH SHRI S. C. AGARWAL (Alternate)

CEMILAC, Bangalore DGAQA, New Delhi/Bangalore DGS&D, Kolkata/New Delhi DMRL, Hyderabad DRDL, Hyderabad Escorts Knowledge Management Centre, Faridabad Hindalco Industries Ltd, Renukoot Hindustan Aeronautics Ltd, Bangalore Indian Space Research Organization, Bangalore Institute of Indian Foundrymen, New Delhi

J. N. Aluminum, R&D Design Centre, Nagpur

Jindal Aluminum Ltd, Bangalore/New Delhi

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IS 16011 : 2012
Organization Ministry of Defence, CQA (Met), Ambernath Ichapur Ministry of Micro, Small and Medium Enterprises (Department of Micro, Small and Medium Enterprises), New Delhi National Aluminium Co Ltd, Bhubneshwar National Metallurgical Laboratory, Jamshedpur National Test House, Ghaziabad Ordance Factory, Ambajhari RDSO (M&C Directorate), Lucknow Regional Research Laboratory, Bhopal Salco Extrusions (P) Ltd, Mumbai Shri Ram Institute of Industrial Research, Delhi Representative(s) SHRI V. H. KAKANI SHRI K. YADAV (Alternate) SHRI J. K. ARYA SHRI V. K. GUPTA (Alternate) SHRI S. NANDA SHRI S. SANKARAN (Alternate) DR K. L. SAHOO DR K. VENKATESHWARLU (Alternate) SHRI R. N. RAM SHRI VINAY SAXENA (Alternate) REPRESENTATIVE SHRI RADHEY SHYAM SHRI V. D. MEHARKURE (Alternate) DR A. K. GUPTA SHRI GOPAL M. PAI SHRIMATI POOJA KAMAT (Alternate) DR P. K. KAICKER SHRIMATI LAXMI RAWAT (Alternate I) SHRI B. GOVINDAN (Alternate II) SHRI P. GHOSH, Scientist `F' and Head (MTD) [Representing Director General (Ex-officio)]

BIS Directorate General

Member Secretary SHRI DEEPAK JAIN Scientist `E' (MTD), BIS

5

Bureau of Indian Standards BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promote harmonious development of the activities of standardization, marking and quality certification of goods and attending to connected matters in the country. Copyright BIS has the copyright of all its publications. No part of these publications may be reproduced in any form without the prior permission in writing of BIS. This does not preclude the free use, in the course of implementing the standard, of necessary details, such as symbols and sizes, type or grade designations. Enquiries relating to copyright be addressed to the Director (Publications), BIS. Review of Indian Standards Amendments are issued to standards as the need arises on the basis of comments. Standards are also reviewed periodically; a standard along with amendments is reaffirmed when such review indicates that no changes are needed; if the review indicates that changes are needed, it is taken up for revision. Users of Indian Standards should ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of `BIS Catalogue' and `Standards : Monthly Additions'. This Indian Standard has been developed from Doc No.: MTD 7(4981) Amendments Issued Since Publication Amend No. Date of Issue Text Affected

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